Response to an Intervention With Omega-3 (RIO - Study)

Launched by UNIVERSIDAD SAN SEBASTIÁN · Aug 1, 2024

Keywords

ClinConnect Summary

The RIO Study is a clinical trial that is looking at how omega-3 fatty acids can help people who are overweight and have high levels of triglycerides, which are fats in the blood. Researchers want to see if taking omega-3 supplements can improve the way the body processes fats and reduces inflammation. The study is currently recruiting participants in Chile who are between 18 and 65 years old, have a body mass index (BMI) between 25 and 29.9, and have fasting triglyceride levels between 100 and 199 mg/dL.

If you join the study, you will be randomly assigned to receive either omega-3 supplements or a placebo (a non-active substance) for a certain period, and then you will switch to the other after a break. This helps researchers compare the effects of the two treatments. Before signing up, it’s important to know that there are some criteria to be eligible, such as not having high blood pressure or uncontrolled other health issues, and you should not have taken omega-3 supplements in the past 10 weeks. Participating in this study may help improve your health and contribute to important research about the benefits of omega-3 for people with similar health conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults between 18 and 65 years old, male and female.
• • Body mass index (BMI) between 25 - 29,9 kg/m2.
• • Fasting triglycerides between 100 - 199 mg/dL (\>1.7 - 2,25 mmol/L).
• Exclusion Criteria:
• • Unable to give informed consent.
• • If you consume Omega-3 (you must stop consumption at least 10 weeks prior).
• • Normal or Obesity Nutritional Status. Large weight variation (\>10%) in the last 3 months.
• • Triglycerides \> 200 mg/dL.
• • Blood pressure \> 140/90 mmHg.
• • Uncontrolled metabolic and chronic diseases (reference parameters for the disease in question will be considered).
• • Pregnant women or those who are breastfeeding.
• • Allergy or intolerance to gluten, milk protein and/or lactose, or any ingredient in the capsules (omega-3, oleic acid oil).
• • Use of medications that affect lipid metabolism: Fibrates. (Statins will be allowed only if the treatment has been ongoing for over 3 months).
• • Blood donation two months before or during the study period.
• • Excessive alcohol consumption (\>3 cans of beer per day)
• • Taking anticoagulants.